04/06/2015

Stated within the eIC draft on page 3, line 66 to 78: "To many, the term informed consent is mistakenly viewed as synonymous with obtaining a handwritten signature from the subject or the subject’s legally authorized representative (LAR) on a written informed consent form. FDA believes that obtaining a subject’s oral or written informed consent is only part of the consent process. Informed consent involves providing a potential subject with adequate information about the research to allow for an informed decision about the subject’s voluntary participation in the clinical investigation. Informed consent must include a process that facilitates the subject’s comprehension of the information and allows adequate opportunity for the subject to ask questions and consider whether or not to participate (21 CFR 50.20). Furthermore, this process often continues beyond obtaining the subject’s initial consent at the time of enrollment. It may involve providing information as the clinical investigation progresses or as the subject or situation requires. The elements of informed consent for human subjects and the requirements for documentation of informed consent are discussed in 21 CFR 50.25 and 50.27, respectively."

Being able to reconstruct this process is important and is more than a statement or sticker that says something like . . . patient was consented prior to study procedures and the patient voluntarily consented to participate in the study. . . This generic statement is not attributable to the process and is like me saying I folowed the protocol without providing proof. Source documentation would be a bunch of affirmations. Thoughts?